Abstract: TH-PO970
Efficiency and Efficacy of Anemia Therapy with Epoetin Beta: Results from a Randomized Controlled Trial of Therapy Software vs. Standard of Care
Session Information
- Anemia in CKD: Risk Factors, Practice Patterns, Therapies
November 02, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Anemia and Iron Metabolism
- 200 Anemia and Iron Metabolism
Authors
- Joerg, David J., Fresenius Medical Care Deutschland GmbH, Bad Homburg, Hessen, Germany
- Fuertinger, Doris H., Fresenius Medical Care Deutschland GmbH, Bad Homburg, Hessen, Germany
- Ho, Kevin, Fresenius Medical Care North America, Waltham, Massachusetts, United States
- Wang, Lin-Chun, Renal Research Institute, New York, New York, United States
- Tisdale, Lela, Renal Research Institute, New York, New York, United States
- Ye, Xiaoling, Renal Research Institute, New York, New York, United States
- Thijssen, Stephan, Renal Research Institute, New York, New York, United States
- Kotanko, Peter, Renal Research Institute, New York, New York, United States
Background
Anemia is common in patients on hemodialysis (HD) and typically treated with erythropoiesis-stimulating agents (ESA). Recurrent ESA dose adjustments are challenging due to delayed effects on patient hemoglobin (Hb) levels and interpatient variability in ESA responsiveness. We developed a novel software providing personalized ESA-dose recommendations based on a mathematical model of anemia. Here, we report results from a randomized controlled trial, comparing the software versus standard-of-care (SOC) anemia treatment in using ESAs efficiently to bring patients’ Hb levels into a given target range.
Methods
We enrolled 96 subjects on HD; 82 of them completed the study. Patients were randomized to be managed by our anemia therapy software (intervention group, “INT”, 40 patients) or continued SOC treatment (42 patients). For 26 weeks, the software generated biweekly patient-specific ESA recommendations to target a Hb of 10–11 g/dL. Recommendations were passed on to clinicians.
Results
In the SOC group, mean Hb levels across the study period showed a negative dependence on the mean amount of ESA per month (Fig. 1A) and total number of ESA administrations during the study period (Fig. 1B). In the INT group, this effect was significantly reduced (Fig. 1). The mean amount of ESA per kg patient weight was also significantly reduced in the INT group (INT: 1.1 [0.6–1.5] mcg/30 days/kg, median [IQR]; SOC: 1.5 [0.9–2.1] mcg/30 days/kg; Wilcoxon rank-sum test, p=0.031) while the number of ESA administrations within the study period was comparable in both groups (INT: 9 [6-10]; SOC: 8 [6-10]; Wilcoxon rank-sum test, p=0.76).
Conclusion
Trial results suggest that our therapy software utilizes ESA more efficiently and controls Hb levels better at low and high ESA dose levels than SOC treatment, while requiring less ESA per kg patient weight and a comparable number of ESA administrations.
Funding
- Commercial Support – Fresenius Medical Care